Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1/2 Study of Vorinostat (Zolinza®) in Combination With Gemtuzumab Ozogamicin (Mylotarg®) and Azacitidine (Vidaza®) in Patients 50 Years of Age and Older With Relapsed/Refractory Non-APL Acute Myeloid Leukemia (AML)
The purpose of this study is to test the safety of vorinostat (Zolinza) and azacitidine (Vidaza) when combined with gemtuzumab ozogamicin (GO) at different dose levels. These drugs increase the effect of GO against leukemia cells in the test tube, but we don't know yet whether they also increase the anti-leukemia effect of GO in people.
PRIMARY OBJECTIVES:
I. Determine the vorinostat dose with the most favorable efficacy and toxicity when combined
with azacitidine and GO.
SECONDARY OBJECTIVES:
I. Describe the complete response (CR)/ CR with inadequate recovery (CRi) rate after a total
of 6 cycles of therapy.
II. Describe the disease-free survival of patients that achieve CR/CRi. III. Determine
whether acute myeloid leukemia (AML) characteristics associated with preclinical GO efficacy
predict for clinical benefit, and assess whether differentiation-inducing agents modulate
these characteristics and lower the apoptotic threshold for calicheamicin-gamma1-induced
cytotoxicity (in vitro correlative and mechanistic studies).
OUTLINE: This is phase I, dose-escalation study of vorinostat followed by a phase II study.
Patients receive vorinostat orally (PO) on days 1-9, azacitidine subcutaneously (SC) or
intravenously (IV) over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours
on day 4 and 8. Treatment repeats every 21 days for up to 12 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years.
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